EN ISO 17511 pdf download In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)、Scope
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators andcontrol materials intended to establish or verify trueness of measurement. The calibrators and control materials arethose provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
External quality assessment (survey) samples, with proven commutability, whose values have been assigned bymeans of internationally agreed reference measurement systems or internationally agreed conventional referencemeasurement systems fall within the scope of this European Standard.
This European Standard is not applicable to:
control materials that do not have an assigned value and are used only for assessing the precision of aameasurement procedure, either its repeatability or reproducibility (precision control materials):
6control materials intended for intralaboratory quality control purposes and supplied with intervals of suggestedacceptable values, each interval obtained by interlaboratory consensus with respect to one specifiedmeasurement procedure, and with limiting values that are not metrologically traceable;
correlation between results of two measurement procedures at the same metrological level, purporting tCmeasure the same quantity, because such horizontal’ correlation does not provide metrological traceability
acalibration derived from correlation between the results of two measurement procedures at differentmetrological levels, but with quantities having analytes of different characteristics:
日metrological traceability of routine results to the product calibrator and their relations to any medicadiscrimination limit;
properties involving nominal scales, .e. where no magnitude is involved (e.q. identification of blood cells
2 Normative references
This European Standard incorporates by dated or undated reference,provisions from other publications.Thesenormative references are cited at the appropriate places in the text, and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).
EN 375:2001, Information supplied by the manufacturer with in vitro diagnostic reagents for professional useInternational Vocabulary of Basic and General Terms in Metrology, 2nd edition, ISO, Geneva, 1993.12)
SO Guide 35:1989, Certification of reference materials – General and statistical principles.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
accuracy of measurement
closeness of the agreement between the result of a measurement and a true value of the measurand